Automation Testing Development for Healthcare Companies
Your healthcare software needs bulletproof testing before it touches real patients. Pi Tech builds automated test suites that catch bugs before regulators do. Ready to ship with confidence?
At Pi Tech, We Build Healthcare Automation Testing That Actually Works. No Drama, No Delays, No Compliance Surprises
We don't just run tests. We build testing systems that speak FDA, understand HIPAA, and catch the bugs that kill medical device launches.
How We Transform Healthcare Testing From Liability to Launch Asset
Regulatory-First Test Architecture
We build test frameworks that map directly to FDA requirements. Every test case traces to a requirement. Every failure gets documented. Every fix gets verified. Your 510(k) submission includes test evidence that actually means something.
• Test cases that map to FDA guidance documents
• Automated traceability from requirements to test results
• Risk-based testing that focuses on patient safety scenarios
• Documentation that auditors understand and accept
Medical Device Testing Automation
Class II device software? SaMD applications? We automate the testing that matters. Performance under load. Data integrity across interfaces. Fail-safe behavior when things break. Your device works or it doesn't ship.
• Load testing that simulates real clinical environments
• Interface testing for HL7, FHIR, and legacy hospital systems
• Failure mode testing that proves your safety mechanisms work
• Real-time monitoring that catches issues before patients do
HIPAA-Compliant Test Data Management
PHI in your test environment is a compliance nightmare. We build test data systems that look real but stay legal. Synthetic patient data. Automated data masking. Test environments that auditors approve of.
• Synthetic data generation that mirrors real patient scenarios
• Automated PHI scrubbing for test environment safety
• Test data refresh processes that maintain compliance
• Audit trails that prove your test data stays clean
Continuous Integration for Healthcare
Your developers push code. Tests run automatically. Compliance checks happen in real-time. Broken builds get caught before they become FDA problems. Ship faster while staying legal.
• Automated regression testing on every code commit
• Compliance validation built into your CI/CD pipeline
• Test result reporting that satisfies quality management systems
• Integration testing that proves your software plays nice with hospital systems
Pi Tech Advantage for Healthcare Automation Testing
Specless Engineering for Testing
We build test frameworks that adapt as your software changes. Requirements shift? Tests evolve. New FDA guidance? Test cases update. Your testing stays current without starting over.
Senior-Only Testing Engineers
Your test automation gets built by people who understand both software and healthcare. No junior developers learning HIPAA on your dime. No test frameworks that break when requirements change.
Regulatory Testing Expertise
We know what the FDA wants to see in your test documentation. Risk analysis that makes sense. Traceability matrices that actually trace. Test evidence that supports your submission.
Healthcare Security Testing
PHI protection isn't optional. We test your encryption, audit your access controls, and verify your data handling. Security testing that keeps the OCR off your back.
Case Study: Automating Compliance Testing for Real-Time Medical Device Software
Xenter's TAVR SmartWire platform captured life-critical cardiac pressure data during heart procedures. Every software update risked breaking something that could impact patient safety. Manual testing? Too slow. Too risky. FDA submission looming.
They needed test automation that understood both software quality and medical device regulations. Most QA teams know one or the other. Rarely both.
Our Solution
Pi Tech built test automation that thought like FDA reviewers, not just QA engineers.
- Created risk-based test scenarios focusing on critical pressure measurements and data accuracy - if the readings were off by even 1%, procedures could fail
- Automated end-to-end testing simulating real TAVR procedures, from device connection through data display in clinical dashboards
- Built compliance documentation automation - every test run generated FDA-ready evidence showing the software met safety requirements
Our automated tests caught edge cases humans missed: data sync issues during network interruptions, UI rendering problems on older hospital tablets, API timeout scenarios that could lose patient data.
The platform passed FDA technical reviews without a single software-related concern. Testing that would've taken weeks now runs in hours with every code change.
Technologies: Selenium (UI automation), Python test frameworks, Jest (API testing), automated HIPAA compliance validators, CI/CD pipeline integration.
When to Outsource Automation Testing Development
Your FDA Submission Needs Bulletproof Test Evidence
Reviewers will scrutinize every test case. Your current testing approach won't survive FDA review. You need test documentation that proves safety, not just functionality. We build test suites that support regulatory approval.
Your Development Team Keeps Breaking HIPAA in Testing
PHI in test environments is a compliance violation waiting to happen. Your developers need realistic test data without real patient information. We create synthetic data systems that look real but stay legal.
Your Manual Testing Can't Keep Up With Development Speed
Agile development meets healthcare compliance requirements. Manual testing creates bottlenecks that kill launch timelines. We automate the testing that matters most for patient safety and regulatory approval.
Your Current Testing Misses the Bugs That Matter
Generic software testing doesn't catch healthcare-specific failures. Medical device software fails differently than consumer apps. We test for the scenarios that happen in clinical environments.
Our Healthcare Automation Testing Development Services
Pi Tech testing services cover everything from test strategy to FDA submission support. We build testing that works in healthcare.
Test Strategy and Framework Development
We design test approaches that align with FDA guidance and your business goals. Risk-based testing strategies that focus resources where they matter most.
Medical Device Test Automation
Automated testing for Class I, II, and III medical devices. Test suites that prove safety, efficacy, and regulatory compliance through repeatable, documented processes.
Healthcare API Testing and Validation
HL7, FHIR, and custom healthcare API testing. We verify data integrity, interface reliability, and system interoperability across complex healthcare technology stacks.
Performance and Load Testing for Clinical Systems
Healthcare systems can't go down during patient care. We test performance under real clinical loads and verify fail-safe behavior when systems reach capacity.
Compliance Testing and Documentation
Test documentation that satisfies FDA, HIPAA, and quality management requirements. Traceability matrices, test reports, and evidence packages that support regulatory submissions.
What Our Clients Say
“In my 20 years of working at technology companies such as Amazon, Groupon, Opendoor, and Jawbone, if I had to pick one person to solve a complicated technology challenge in the shortest time possible, Michael [CTO @ Pi Tech] would be at the top of my list. He is resourceful, scrappy, and has focus, unlike anyone I have ever seen.”
Jason Child
CFO, Arm - Former CFO, Splunk, OpenDoor, Groupon
“In my 20 years of working at technology companies such as Amazon, Groupon, Opendoor, and Jawbone, if I had to pick one person to solve a complicated technology challenge in the shortest time possible, Michael [CTO @ Pi Tech] would be at the top of my list. He is resourceful, scrappy, and has focus, unlike anyone I have ever seen.”
Jason Child
CFO, Arm - Former CFO, Splunk, OpenDoor, Groupon
"We’re impressed with their ability to exceed our expectations and go beyond the scope of the project. In addition, they’re very flexible and highly capable of delivering quality work."
David Hose
COO, Blockware Solutions
"Working with Pi Tech was very easy. They streamlined and managed their engineering time to avoid a large bill, and I was pleasantly surprised with their delivery."
Pat Downing
CTO, Action Title Research
"Michael [Pi Tech CTO] relishes tackling and solving the toughest technical problems. He has the ability to almost intuitively find the core of a solution to a difficult problem, but understands and practices the principle that the core idea to solving a difficult problem is often the first step in a long process to achieve a fully workable solution. He has an extraordinary work ethic, and focuses until the job is completely done."
Ross Bott
President & CEO, SEVEN Networks
Ready to Build Healthcare Testing That Actually Works?
Your software testing determines whether patients get better or your company gets sued. Generic testing approaches don't work in healthcare. You need testing that understands both software and medicine.
Pi Tech builds automated test suites that prove your software works when lives depend on it.
FAQ
We’re here to answer your questions. More questions? View our full FAQ, or Get in Touch.
get in touch
Discover how our expertise can drive your business forward. Get in touch today.
